FDA Review Panel · OR

FDA 510(k) Orthopedic Devices

FDA 510(k) Orthopedic Devices - Regulatory Overview

FDA 510(k) orthopedic devices include implants, instruments and systems used in musculoskeletal surgery and rehabilitation. The FDA review panel code is OR.

Key categories:

  • Joint replacement implants - hip, knee, shoulder and ankle prostheses
  • Bone fixation systems - plates, screws, nails and external fixators
  • Spinal implants - cages, rods, pedicle screws and disc replacements
  • Surgical navigation - image-guided and robotic-assisted orthopedic surgery
  • Bone grafts and substitutes - synthetic and allograft bone repair materials

With 17,685 submissions, this is one of the largest 510(k) categories. Data sourced from FDA 510(k) public files. Updated monthly.

17985
Total
17965
Cleared
117d
Avg (2y)
1976
Since
17608 Orthopedic devices
8051–8075 of 17608
Cleared Jan 05, 2012
PROMOS MODULAR SHOULDER SYSTEM
K113012 · Smith & Nephew, Inc.
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 86d
Cleared Jan 05, 2012
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS
K113038 · Smith & Nephew, Inc.
HSX · Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer · 85d
Cleared Jan 05, 2012
APEX ARC HIP STEM
K113242 · Omni Life Science, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 64d
Cleared Jan 04, 2012
DYNA LOCKING CANNULATED SCREW
K112240 · U&I Corp.
HWC · Screw, Fixation, Bone · 153d
Cleared Jan 04, 2012
FOCUS MIS SYSTEM
K112643 · L & K Biomed Co., Ltd.
NKB · Thoracolumbosacral Pedicle Screw System · 114d
Cleared Jan 04, 2012
DNE EXTERNAL FIXATION SYSTEM
K113106 · Dne, LLC
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 76d
Cleared Jan 04, 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
K113609 · Exactech, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 29d
Cleared Dec 30, 2011
STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
K111068 · Skeletal Dynamics, LLC
KYI · Prosthesis, Wrist, Carpal Trapezium · 256d
Cleared Dec 29, 2011
LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS
K113559 · Ldr Spine USA, Inc.
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 28d
Cleared Dec 28, 2011
ARTS2 SPINAL FIXATION SYSTEM
K103573 · Advanced Medical Technologies
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 387d
Cleared Dec 28, 2011
PRESERVE HIP STEM
K112080 · Wrightmedicaltechnologyinc
KWA · Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) · 160d
Cleared Dec 27, 2011
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM
K112923 · Suspension Orthopaedic Solutions, LLC
HRS · Plate, Fixation, Bone · 85d
Cleared Dec 23, 2011
ZAVATION IBF SYSTEMS
K112664 · Zavation, LLC
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 101d
Cleared Dec 23, 2011
STRYKER RESORBABLE FIXATION SYSTEM
K113109 · Stryker
HRS · Plate, Fixation, Bone · 64d
Cleared Dec 22, 2011
CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
K112907 · Medos International SARL
NDN · Cement, Bone, Vertebroplasty · 80d
Cleared Dec 22, 2011
COLS PEEK
K113591 · Fournitures Hospitalieres Industrie
HWC · Screw, Fixation, Bone · 17d
Cleared Dec 21, 2011
ARTHREX FRACTURE SYSTEM
K112437 · Arthrex, Inc.
HTN · Washer, Bolt Nut · 119d
Cleared Dec 21, 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112920 · K2m, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 79d
Cleared Dec 21, 2011
SYNTHES MIRS
K113044 · Synthes Spine
NKB · Thoracolumbosacral Pedicle Screw System · 70d
Cleared Dec 20, 2011
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS
K112941 · Smith & Nephew, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 77d
Cleared Dec 20, 2011
MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS
K113028 · Medisiss
HRX · Arthroscope · 70d
Cleared Dec 20, 2011
IFS SUBTALAR IMPLANT
K113399 · Internal Fixation Systems, Inc.
HWC · Screw, Fixation, Bone · 33d
Cleared Dec 20, 2011
LIMACORPORATE SMR REVERSE SHOULDER SYSTEM
K113523 · Lima Corporate S.P.A.
PHX · Shoulder Prosthesis, Reverse Configuration · 21d
Cleared Dec 20, 2011
CLYDESDALE(R) SPINAL SYSTEM
K113528 · Medtronic Sofamor Danek USA, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 20d
Cleared Dec 20, 2011
HEALIX KNOTLESS ANCHOR
K113534 · Depuy Mitek, A Johnson & Johnson Company
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 20d

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All categories 17608 HRS Plate, Fixation, Bone 1319 HWC Screw, Fixation, Bone 1051 JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer 915 NKB Thoracolumbosacral Pedicle Screw System 914 MAX Intervertebral Fusion Device With Bone Graft, Lumbar 897 KWQ Appliance, Fixation, Spinal Intervertebral Body 664 HRX Arthroscope 632 MBI Fastener, Fixation, Nondegradable, Soft Tissue 604 LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented 560 JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented 545 LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented 531 HSB Rod, Fixation, Intramedullary And Accessories 517 MQV Filler, Bone Void, Calcium Compound 493 OLO Orthopedic Stereotaxic Instrument 439 KWP Appliance, Fixation, Spinal Interlaminal 417